Evaluating outcomes for mothers and infants after exposure to Rimegepant during pregnancy
A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)
This study is trying to see how taking the migraine medication Rimegepant during pregnancy affects the health of mothers and their babies compared to those who didn't take it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 780 (estimated) |
| Ages | 0 Years and up |
| Sex | Female |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT05046613 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the maternal, fetal, and infant outcomes for pregnant women diagnosed with migraines who have been exposed to Rimegepant, a medication used for migraine treatment. It will compare outcomes between those who have taken Rimegepant during pregnancy or just before conception and those who have not been exposed to the drug. The study will follow participants and their infants for up to 12 months to gather comprehensive data on health outcomes. The research is sponsored by Pfizer and conducted in collaboration with PPD.
Who should consider this trial
Good fit: Ideal candidates include pregnant women with a diagnosis of migraine who have either been exposed to Rimegepant or have not taken it during pregnancy.
Not a fit: Patients who have been exposed to other CGRP antagonists or ditans during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of Rimegepant on pregnant women and their infants.
How similar studies have performed: While there have been studies on migraine treatments during pregnancy, this specific observational approach to Rimegepant is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception) * Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy Exclusion Criteria: • Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy
Where this trial is running
Wilmington, North Carolina
- Evidera, a PPD business unit — Wilmington, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.